Effect of Biannual Mass Azithromycin Distributions to Preschool-Aged Children on Trachoma Prevalence in Niger
Authors: Ahmed M. Arzika, Dallas Mindo-Panusis, Amza Abdou, Boubacar Kadri, Beido Nassirou, Ramatou Maliki, Amer F. Alsoudi, Tianyi Zhang, Sun Y. Cotter, Elodie Lebas, Kieran S. O’Brien, E. Kelly Callahan, Robin L. Bailey, Sheila K. West, E. Brook Goodhew, Diana L. Martin, Benjamin F. Arnold, Travis C. Porco, Thomas M. Lietman, Jeremy D. Keenan, Paul M Emerson, Huub Gelderblom, PJ Hooper, Jerusha Weaver, Sheila K West, Robin L Bailey, John Hart, Amza Abdou, Nassirou Beido, Boubacar Kadri, Maria M Ali, Mankara K Alio, Ahmed Arzika, Nameywa Boubacar, E Kelly Callahan, Sanoussi Elh Adamou, Nana Fatima Galo, Fatima Ibrahim, Salissou Kane, Mariama Kiemago, Ramatou Maliki, Aisha E Stewart, Cindi Chen, Catherine Cook, Sun Y Cotter, Thuy Doan, Bruce D Gaynor, Armin Hinterwirth, Jeremy D Keenan, Elodie Lebas, Thomas M Lietman, Ying Lin, Kieran S O'Brien, Catherine E Oldenburg, Travis C Porco, David A Ramirez, Kathryn J Ray, Philip J Rosenthal, George W Rutherford, Benjamin Vanderschelden, Nicole E Varnado, John P Whitcher, Dionna M Wittberg, Lee Worden, Lina Zhong, Zhaoxia Zhou
Journal: JAMA Network Open (2022)

Because transmission of ocular strains of Chlamydia trachomatis is greatest among preschool-aged children, limiting azithromycin distributions to this age group may conserve resources and result in less antimicrobial resistance, which is a potential advantage in areas with hypoendemic trachoma and limited resources.To determine the efficacy of mass azithromycin distributions to preschool-aged children as a strategy for trachoma elimination in areas with hypoendemic disease.In this cluster randomized clinical trial performed from November 23, 2014, until July 31, 2017, thirty rural communities in Niger were randomized at a 1:1 ratio to biannual mass distributions of either azithromycin or placebo to children aged 1 to 59 months. Participants and study personnel were masked to treatment allocation. Data analyses for trachoma outcomes were performed from October 19, 2021, through June 10, 2022.Every 6 months, a single dose of either oral azithromycin (20 mg/kg using height-based approximation for children who could stand or weight calculation for small children) or oral placebo was provided to all children aged 1 to 59 months.Trachoma was a prespecified outcome of the trial, assessed as the community-level prevalence of trachomatous inflammation-follicular and trachomatous inflammation-intense through masked grading of conjunctival photographs from a random sample of 40 children per community each year during the 2-year study period. A secondary outcome was the seroprevalence of antibodies to C trachomatis antigens.At baseline, 4726 children in 30 communities were included; 1695 children were enrolled in 15 azithromycin communities and 3031 children were enrolled in 15 placebo communities (mean [SD] proportions of boys, 51.8% [4.7%] vs 52.0% [4.2%]; mean [SD] age, 30.8 [2.8] vs 30.6 [2.6] months). The mean coverage of study drug for the 4 treatments was 79% (95% CI, 75%-83%) in the azithromycin group and 82% (95% CI, 79%-85%) in the placebo group. The mean prevalence of trachomatous inflammation-follicular at baseline was 1.9% (95% CI, 0.5%-3.5%) in the azithromycin group and 0.9% (95% CI, 0-1.9%) in the placebo group. At 24 months, trachomatous inflammation-follicular prevalence was 0.2% (95% CI, 0-0.5%) in the azithromycin group and 0.8% (95% CI, 0.2%-1.6%) in the placebo group (incidence rate ratio adjusted for baseline: 0.18 [95% CI, 0.01-1.20]; permutation P = .07).The findings of this trial do not show that biannual mass azithromycin distributions to preschool-aged children were more effective than placebo, although the underlying prevalence of trachoma was low. The sustained absence of trachoma even in the placebo group suggests that trachoma may have been eliminated as a public health problem in this part of Niger.ClinicalTrials.gov Identifier: NCT02048007.